Intervention Review

You have free access to this content

Surgical interventions for the early management of Bell's palsy

  1. Kerrie McAllister1,
  2. David Walker1,
  3. Peter T Donnan2,
  4. Iain Swan3,*

Editorial Group: Cochrane Neuromuscular Disease Group

Published Online: 16 OCT 2013

Assessed as up-to-date: 29 OCT 2012

DOI: 10.1002/14651858.CD007468.pub3


How to Cite

McAllister K, Walker D, Donnan PT, Swan I. Surgical interventions for the early management of Bell's palsy. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD007468. DOI: 10.1002/14651858.CD007468.pub3.

Author Information

  1. 1

    North Glasgow University NHS Trust, Department of Otolaryngology, Glasgow, UK

  2. 2

    University of Dundee, Tayside Centre for General Practice, Dundee, UK

  3. 3

    Glasgow Royal Infirmary, Glasgow, UK

*Iain Swan, Glasgow Royal Infirmary, Department of Otolaryngology, Royal Infirmary, Glasgow, G31 2ER, UK. Iain@ihr.gla.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 16 OCT 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Adour 1971

MethodsRandomised controlled study conducted through a Facial Paralysis Research Clinic which received referrals from 14 various clinics (Permanente Medical group, Kaiser Foundation Hospital, Oakland, California). The study participants were followed up for 9 months. A parallel group of 264 participants with Bell's palsy not included in the study were followed up for 1 month


Participants44 participants were included in the surgical study (considered the treatment of 403 patients)

Inclusion was based upon an extensive clinical examination.

Participants had to fit three criteria: a clinically complete nerve palsy, no contraindication to general anaesthesia and an increased nerve excitability shown by a difference between the affected and unaffected sides

Surgery group: 23 participants, mean age 36.8 years, male:female ratio 10:13

Control group: 21 participants, mean age 48.2 years, male:female ratio 8:13

Participants were members of Kaiser Foundation Health plan (paid health care programme of 900,000 subscribers) in San Francisco Bay area. General health of members, including age distribution were thought to be representative of the general population


InterventionsParticipants were randomised into a surgical and non-surgical group. Interventions were: no surgery, surgery within 48 hours of onset of denervation, surgery 8 to 12 weeks after onset of denervation. Some participants declined surgery and were added to the non-surgical group.

All the participants in the operative group were decompressed using a retro-auricular approach. The non-surgical group were treated with prednisolone beginning with a dose of 40 mg and tapering to 5 mg at the end of eight days


OutcomesFacial Paralysis Recovery Profile (FPRP) and the Facial Paralysis Recovery Index (FPRI) were used to measure outcomes. The scales were developed by the authors for this study and used for their subsequent studies. The FPRP score ranges from +2 for no recovery to +10 for complete recovery. The FPRI score ranges from -12 to +10 (the FPRP score minus points for complications)

Synkinesis and other clinical features listed individually but not compared between the different study groups

The outcomes were measured at 1, 2, 3, 6 and 9 months


NotesThe study was supported by a Public Health Service general research support grant from the National Institutes of Health. There was no declared conflicts of interest among the main researchers in the study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "the attempt at randomisation into equal groups was made. Completely random distribution could not be effected because some patients and some patients' physicians, refused surgical intervention."

Comment: The method of randomisation used was not described. Some participants who declined surgery were added to the non-surgical group

Allocation concealment (selection bias)Unclear riskThere was no mention of any attempted method of allocation concealment

Blinding (performance bias and detection bias)
All outcomes
High riskBlinding of the participant to either a surgical and non-surgical intervention was not possible. Blinding of the investigator/outcome assessor was not commented on and would have been difficult to perform in this study because of the surgical intervention involved

Incomplete outcome data (attrition bias)
All outcomes
High riskQuote: "one patient was lost to follow-up"

Comment: 1/23 participants in the operated group was lost to follow-up and was commented on. However, 6/21 participants from the control group were lost to follow-up at the 9 month assessment (reasons not given) and other omissions in data are not mentioned in the text.

Selective reporting (reporting bias)Low riskAll pre-specified outcomes were reported on

Other biasLow riskAppears to be free of other sources of bias

Mechelse 1971

MethodsA randomised controlled study conducted simultaneously at 2 centres. Participants not included in the study because of good prognosis were also followed up. Both participants and the parallel study group were followed up for 1 year


Participants25 participants were selected on the basis of a complete facial palsy and electromyography showing no voluntary control of motor unit or a minimal applied current evoking a motor response on the affected side 2.5 times that of the unaffected side. These responses needed to be confirmed on two occasions a few days apart. 1 participant refused surgery and was excluded from the study

Surgery group: 11 participants, mean age 45.3 years, male to female ratio 1:10, side of idiopathic facial palsy left:right = 7:4

Control group: 13 participants, mean age 45 years, male to female ratio 8:5, side of idiopathic facial palsy left:right = 6:7

This study did not report if there were statistically significant differences between the two groups


InterventionsAll the participants in the surgical group were decompressed using a retro-auricular approach. The control group had no treatment


OutcomesOutcome assessed using a scale of 0 to 5 (0 no function, 5 complete function). Study report does not state statistical methods used


Notes2 Centres participating in study: University Hospital, Leiden and Municipal Hospital, The Hague, Netherlands. There was no sponsorship noted. There was no declared conflicts of interest among the main researchers in the study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "in both hospitals these patients were entered on a list, previously prepared by the statistical department, University of Leiden (head, Mr H. De Jonge), which randomly allocated them to surgical treatment or to a control group"

Comment: 25 participants were randomly allocated into surgical or control groups as stated above. It is stated that one participant declined surgery and was removed from the study

Allocation concealment (selection bias)Unclear riskThere is no comment on any attempted method of allocation concealment

Blinding (performance bias and detection bias)
All outcomes
High riskBlinding of the participant to either a surgical and non-surgical intervention was not possible. Report does not comment on blinding of the investigator/outcome assessor, which would have been difficult to perform in this study because of the surgical intervention involved

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: "All patients were followed clinically and electromyographically for a least a year"

Comment: complete follow-up with no losses

Selective reporting (reporting bias)Low riskAll pre-specified outcomes were reported

Other biasLow riskAppears to be free of other sources of bias

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Aoyagi 1988Included participants were not randomised into surgical or non-surgical groups

Brown 1982Retrospective audit. Study does not compare outcomes between the groups and does not describe how surgery and no-surgery groups were selected

Fisch 1981Retrospective study. No description is given as to how participants were allocated to the surgically treated or not surgically treated groups. No discussion about the non-surgical group. Only 14 participants underwent surgery

Gantz 1999No randomisation. Participants self selected whether or not to have surgery. 11 out of 30 participants offered surgery declined, therefore only 19 out of 169 evaluated had surgery

Giancarlo 1970No randomisation. Participants self selected whether or not to have surgery. Also, report does not describe the degree of baseline clinical palsy, merely that the nerve was degenerating

May 1984Prospective audit. No attempt at randomisation. Control group either self selected, considered poor surgical risk or had already received corticosteroids. 50 participants underwent surgery with a control group of 35. However, statistical comparison was performed on only the poorest prognostic groups of 25 surgical and 13 non-surgical participants which showed no statistically significant difference

McNeill 1974Retrospective audit. Participants self selected whether or not to have surgery. Control group either declined surgery or were considered poor surgical risk

Yanagihara 2001Participants had trial of corticosteroids initially before being considered for surgery. There was no randomisation. Participants self selected whether or not to have surgery. Report notes that younger participants opted for surgery and older participants refused surgery

 
Summary of findings for the main comparison. Surgery for Bell's palsy versus medical treatment (oral prednisolone) or no treatment

Surgery for Bell's palsy

Patient or population: Bell's palsy
Settings: hospital attendance with idiopathic facial paralysis
Intervention: surgery

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlSurgery

Recovery of facial nerve function at 12 months
Follow-up: 12 months
See commentSee commentNot estimable69
(2 studies)
⊕⊝⊝⊝
very low1,2
One study did not perform statistical analysis, one did not state the method used. Different outcome measures in each study made combining results impractical.

Side effects and complications of treatment
clinical assessment
Follow-up: 12 months
See commentSee commentNot estimable69
(2 studies)
⊕⊝⊝⊝
very low1
The numbers involved in the included studies were small and statistical analysis was not possible.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Limitations in study design: in one study the method of randomisation was not described. There were small numbers in both studies and large numbers were not followed up in one study. One study followed participants up to 9 months not 12 months. In both studies there was unclear allocation concealment and outcome assessors were not blinded.
2 No evidence of publication bias for this outcome.